BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3140517 · Received May 31, 2013

    Report

    Report Number
    3015876-2013-00461
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE DEVICE HAD SUSTAINED IMPACT DAMAGE TO THE FRONT CASE AND THE THERAPY CONNECTOR. THIS DAMAGE ALSO CAUSED ONE OF THE PINS WITHIN THE CONNECTOR TO HAVE BEEN PUSHED IN.PHYSIO-CONTROL REPLACED THE THERAPY CONNECTOR ASSEMBLY ALONG WITH THE FRONT CASE AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE THERAPY CONNECTOR ON THEIR DEVICE WAS PUSHED BACK INTO THE UNIT; THEREFORE A THERAPY CABLE COULD NOT BE CONNECTED AND DEFIBRILLATION WOULD NOT BE AVAILABLE, IF NECESSARY. THE CUSTOMER WAS UNSURE HOW OR WHEN THE DAMAGE OCCURRED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241143 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1